FSP – Associate Safety Specialist

Role overview

FSP – Associate Safety Specialist at Thermo Fisher Scientific

Prepares and maintains regulatory safety reports.

Responsibilities

• You will perform activities such as adverse event data entry, coding, assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities.
• Work is performed in an office environment with exposure to electrical office equipment .
• Education and Experience Requirements.
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision.

Employment details

• Location: Remote [India]

Benefits

• Maintains medical understanding of applicable therapeutic area and disease .

Additional role details

• Join Us as Associate Safety Specialist – Make an Impact at the Forefront of Innovation.
• As Associate Safety Specialist, you'll perform day-to-day Pharmacovigilance (PV) activities within a highly regulated environment driven by strict timelines.
• You will effectively collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors.
• Performs day-to-day PV activities.
• May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.
• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
• Reviews cases entered for quality, consistency and accuracy, including review of peer reports.
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification .
• Strong critical thinking and problem solving skills.
• Good oral and written communication skills including paraphrasing skills .
• Good command of English and ability to translate information into local language where required .
• Computer literate with the ability to work within multiple databases .
• Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel) .
• Understanding of medical terminology .
• Strong attention to detail .
• Ability to maintain a positive and professional demeanor in challenging circumstances .
• Ability to work effectively within a team to attain a shared goal .
• Daily exposure to high pressure and intense concentration .
• Daily interactions with clients/associates .
• Travel required on occasion domestic and/or international.